Alnylam has abandoned plans to add cardiomyopathy to the label for transthyretin-mediated amyloidosis (ATTR) therapy Onpattro after the FDA turned down its marketing appli
An FDA advisory committee has voted that Amgen’s confirmatory phase 3 trial for KRAS inhibitor Lumakras is not enough to support full approval, but it seems unlikely that
Takeda has decided to withdraw its cancer drug Exkivity from the market, after a trial that was supposed to confirm its efficacy failed to deliver a positive result.
Problems at a contract manufacturing organisation have scuppered Eli Lilly’s hopes of a timely FDA approval for lebrikizumab, its IL-13 inhibitor for the treatment of atop
A trade organisation representing pharma manufacturers in Europe has said plans to restrict the use of fluorinated substances known as PFAS could make manufacturing “grind